The efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression and brain functional changes compared to venlafaxine: A four week, double-blind, parallel, randomized study with an eight week, open-label, follow-up study

Ministry of Health, Czech Republic0 个研究点目标入组 57 人开始时间: 2015年10月2日最近更新: 2022年10月24日

适应症

试验速览

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31695391 results (added 02/04/2020)

•1. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of the American Psychiatric Association-IV. revision criteria, confirmed using The Mini-International Neuropsychiatric Interview - M.I.N.I., Czech version 5.0.0
•2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush (=1 previous, unsuccessful, adequate, antidepressant treatment)
•3. The mental ability to understand and sign Informed Consent Form
•4. The score in the Montgomery and Åsberg Rating Scale (MADRS) =25 and the score in Clinical Global Impression =4
•5. Inpatients in the double-blind phase of treatment
•6. Age between 18 and 65 years
•7. Right handedness

•1. Psychiatric comorbidity on axis I and II according to DSM IV in the 6 months before enrollment to the study
•2. Psychotic, bipolar disorder or dementia in the history
•3. Contraindications of venlafaxine treatment according to SPC
•4. Contraindications of MRI (metallic plates in the head, applied pacemaker or other electronic
•stimulation devices, etc.)
•5. Contraindications of tDCS (skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, metallic plates in the head)
•6. Pregnancy or breast-feeding
•7. Patients with severe somatic disorders (cardiovascular disease, neoplasms, endocrinology
•disorders etc.) that could be associated with depression due to somatic diseases
•8. Patients treated with electroconvulsive therapy less than 3 months before enrollment or suffering
•from neurologic disorder (e.g., epilepsy, head trauma with loss of consciousness) and patients using any treatment which can strongly affect EEG
•9. Application of other concomitant medication that is not allowed in protocol (e.g. antipsychotics,
•mood stabilizers etc.)
•10. Unsuccessful treatment with venlafaxine or tDCS in the current episode of depressive disorder
•11. Fluoxetine treatment before the enrollment to the study

发起方

Ministry of Health, Czech Republic